Scanning the horizon for high value-add manufacturing science: Accelerating manufacturing readiness for the next generation of disruptive, high-value curative cell therapeutics.

BACKGROUND: Since the regenerative medicine sector entered the second phase of its development (RegenMed 2.0) more than a decade ago, there is increasing recognition that current technology innovation trajectories will drive the next translational phase toward the production of disruptive, high-value curative cell and gene-based regenerative medicines.

AIM: To identify the manufacturing science problems that must be addressed to permit translation of these next generation therapeutics.

METHOD: In this short report, a long lens look within the pluripotent stem cell therapeutic space, both embryonic and induced, is used to gain early insights on where critical technology and manufacturing challenges may emerge.

CONCLUSION: This report offers a future perspective on the development and innovation that will be needed within manufacturing science to add value in the production and commercialization of the next generation of advanced cell therapies and precision medicines.